البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Loperamide hydrochloride
PCO Manufacturing Ltd.
A07DA; A07DA03
Loperamide hydrochloride
2 milligram(s)
Capsule, hard
Product not subject to medical prescription
Antipropulsives; loperamide
Authorised
2005-11-28
_ _ _ _ ARRET ® 2 MG HARD CAPSULES loperamide hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. – This medicine is used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. – DO NOT TAKE THIS MEDICINE: - There are some people who should not use this medicine. To find out if you are one of them. See Section 2_ _ ▶ - If you are allergic to loperamide or any of the other ingredients of this medicine. – SPEAK TO YOUR DOCTOR: - If you suffer from any of the conditions mentioned in Section 2_ _ ▶ - If you are taking any other medicines. See Section 2 ▶ – FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in the dosage table. See Section 3_ _ ▶ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 ▶ • You must talk to a doctor if you do not feel better or if you feel worse after 24 hours. WHAT IS IN THIS LEAFLET 1. What ARRET Capsules are, and what they are used for. 2. What you need to know before you take ARRET Capsules. 3. How to take ARRET Capsules. 4. Possible side effects. 5. How to store ARRET Capsules. 6. Contents of the pack and other information. 1. WHAT ARRET CAPSULES ARE AND WHAT THEY ARE USED FOR ARRET Capsules is a medicine which is used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 12 years and over. The capsules contain loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from the bowel. ARRET Capsules should be used in conjunction with oral reh اقرأ الوثيقة كاملة
Health Products Regulatory Authority 05 April 2023 CRN00DHCV Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arret 2 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 2 mg loperamide hydrochloride. Excipient with known effect Each capsule contains lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule _Product imported from Greece_ Purple and green hard gelatin capsules containing a white powder. 4 CLINICAL PARTICULARS As per PA0330/042/001 5 PHARMACOLOGICAL PROPERTIES As per PA0330/042/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Maize starch Talc Magnesium stearate Titanium dioxide (E171) Yellow ferric oxide (E172) Indigotin Gelatin Erythrosine sodium 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Store in the original package. Health Products Regulatory Authority 05 April 2023 CRN00DHCV Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 6 and 12 capsules contained in an outer cardboard carton. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/155/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 November 2005 Date of last renewal: 28 November 2010 10 DATE OF REVISION OF THE TEXT April 2023 اقرأ الوثيقة كاملة